Compounding pharmacies can heal — but sometimes hurt

Sunday

Aug 4, 2013 at 6:10 PM

Annie McGill is reminded daily of the disease that nearly killed her. More than a decade ago, the 76-year-old Laurinburg, N.C., woman was infected with fungal meningitis from a contaminated steroid injection made in Spartanburg.

By KIM KIMZEY and FELICIA KITZMILLERkim.kimzey@shj.com and felicia.kitzmiller@shj.com

Annie McGill is reminded daily of the disease that nearly killed her.More than a decade ago, the 76-year-old Laurinburg, N.C. woman was infected with fungal meningitis from a contaminated steroid injection made in Spartanburg.McGill can barely walk and she can't drive. Her body hurts from head to toe, and she has frequent headaches.“I'm still in doctors' offices,” she said in a phone interview with the Herald-Journal. “It damaged all the different parts of my body … But I'm lucky not to be dead.Legislators have advanced a bill in the U.S. Senate that establishes measures aimed to help prevent another outbreak of infections from drugs produced in compounding facilities, as well as implement a uniform way to track the dispersal if drugs.A coalition of U.S. Senators recently urged action on the legislation.The Pharmaceutical Quality, Security and Accountability Act, if passed, would distinguish between traditional compounders and compounding manufacturers, and bring the later under the supervision of the U.S. Food and Drug Administration.The bill is in response to a fungal meningitis outbreak that began in the fall of 2012 and led to 61 deaths and 749 illnesses.As she watched the latest outbreak unfold, McGill questioned if anything was learned from the 2002 outbreak that sickened her and several others.The Spartanburg-produced steroid injections that caused the earlier outbreak were contaminated with wangiella dermatitidis, a fungus typically found in soil, wood and other organic debris. The tainted steroid caused a meningitis outbreak that killed two people in North Carolina, and left others, like McGill, scarred.“I'm still aching and ailing with it,” McGill said. “I'll have to deal with it until I die, I guess.”

McGill said she was receiving steroid injections to combat a back injury she sustained while working as a nurse. That summer, she became very sick with a high fever and was temporarily blinded.“I was really, really, really sick,” she said. “Nobody could find out what happened to me.”She was later diagnosed at a hospital in Chapel Hill, N.C.People infected by the meningitis outbreak received steroid injections at Johnston Pain Clinic in Jacksonville, N.C. and Pinehurst Anesthesia Associates in Pinehurst, N.C. Because meningitis can take months to present itself, the number of cases associated with the outbreak is not entirely clear. Reports range from four to seven.Two people, Vivian Conrad and Mary Virginia Scyster, died as a result of the infection.Investigators traced the contaminated drug to Urgent Care Pharmacy formerly located on Winchester Place just off W.O. Ezell Boulevard.An investigation by the South Carolina Board of Pharmacy found the Spartanburg compounding pharmacy did not maintain the “required standards of sterilization for compounding pharmacies” and did not properly maintain the environment and equipment used to compound the drugs. Technicians were also found to have insufficient oversight and training, logs were not properly kept, and there were no written procedures.Urgent Care Pharmacy was also accused of violating the South Carolina Pharmacy Practice Act by failing to establish a relationship with the practitioners and patients to receive their drugs and failed to verify the drugs would only be used in-office by the doctors placing the order. These guidelines are what allow compounding pharmacies to escape the stringent federal regulations of drug manufacturers.In September 2002, Urgent Care Pharmacy was ordered to cease compounding practices, but potentially infected drugs had already been distributed to 11 states. A subsequent inspection by the FDA led to a nationwide alert and about all injectable drugs produced by the pharmacy. Some patients who were possibly exposed to the drug received warning letters, urging them to immediately seek medical help for a list of symptoms including fever, nausea, neck stiffness, and acute headaches.The facility closed after the investigation and never reopened.

The pharmacist in charge of the facility, Ken Mason, was fined $10,000 and his license put on probationary status for four years as a result of the outbreak, according to a consent order from October 2006.McGill and others infected by Urgent Care's products filed a lawsuit to seek restitution, which was later settled out of court. This more than anything, not being able to address those who affected her life so dramatically in open court, angers McGill.“I want people to hear me,” she said. “We trusted them. We put our lives in someone else's hands.”The 2002 outbreak brought compounding under scrutiny in South Carolina. Lesia Kudelka, a spokeswoman for the Board of Pharmacy, said the agency increased the priority of compounding facility inspections and provided additional training to inspectors.They also formed policies specific to compounding and formed committees to examine and update the laws, including a bill submitted for the 2013 legislative session. The bill requires a licensed pharmacist to make a final check of all drugs compounded by a technician and enhances requirements for the facilities used for compounding. The bill passed in the House of Representatives and Senate Medical Affairs Committee. It is on the calendar for the full Senate to debate when they reconvene in January.

Compounding came under national scrutiny after the 2012 outbreak, which was traced to a compounding facility in Framingham, Mass.As the outbreak grew in scope for several months, people across the country began asking how a medicine that was supposed to take away their pain could be contaminated with a strain of mold with the potential to make them lethally ill.According to the Centers for Disease Control, a healthcare facility in Mt. Pleasant, S.C. was among those that received lots of the recalled steroid, which also was recalled from facilities in surrounding states.

Kathy Quarles Moore with the S.C. College of Pharmacy said compounding pharmacies make customized medications to meet patients' needs. She said some patients may be allergic to an ingredient in a commercial product, may be unable to swallow medication, or have another need that necessitates a specialized medicine from a compounding pharmacy.Compounded drugs may be non-sterile or sterile.Sterile compounded drugs are generally more high risk than non-sterile drugs. Different criteria govern the production of them.Nancy Culberson Taylor, also with the S.C. College of Pharmacy, said sterile compounded drugs include those drugs injected into the body. There are more stringent restrictions on procedures and quality for sterile drugs. Compounders take precautions to guard against contamination, and test products for quality and sterility.Moore said non-sterile compounded drugs could include topical medications or a suspension that's swallowed.In South Carolina, the state Board of Pharmacy inspects compounding pharmacies.“The board's job is to protect the public,” Moore said.Taylor said concerned patients can ask pharmacists about their standard operating procedures, may be allowed to observe the area where compounded drugs are made, inquire about the training of personnel and how the compounding pharmacy takes steps to prevent contamination and ensure the quality of products.Shertech Compounding Pharmacy has become known as the “go to” for medication one can't find elsewhere, said co-owner and pharmacy manager Russell Prescott III.He said the Spartanburg pharmacy was established in 1995, he took over in 1999 and the business began compounding around 2000.

Prescott said compounding pharmacies fulfill a “big need” making backordered medicines — a list he described as “huge.”Prescott said there are various reasons for backorders. A drug manufacturer might have been cited during an inspection and cannot manufacture a drug until an issue is resolved. He said the consolidation of manufacturers may also create shortages when there's increased demand they can't keep up with order requests.In addition to drug shortages, compounded drugs may be made for dosage adjustment, different ways to administer the drug or a child may need a smaller concentration of a drug for which there's no pediatric dosage.Prescott said the pharmacy's drugs are tested for sterility, potency and other qualities at facilities in Texas and Colorado.“Oversight's the biggest thing,” Prescott said, when it comes to ensuring safety of compounded drugs.“In our situation, we're as traditional of a compounding pharmacy as you can get,” he said.Shertech supplies local hospitals and physicians with various medications.Prescott said the business has a couple of pharmacists and technicians and produce a limited amount of product to fulfill local needs. Because batch quantities are small, he said their oversight is very hands on.Prescott said all of their sterile compounding is done by a pharmacist, but said there is nothing wrong with a company that has technicians make sterile drugs if the technician has the proper training.Shertech also buys sterile vials, but said other compounding pharmacies may buy non-sterile vials that they sterilize to cut costs, which he could see if they are making a large volume of drugs.

Everett Waldrep with Shertech said most physicians the pharmacy serves have not questioned them since last year's fungal meningitis outbreak.“I really thought we would get a lot more feedback from the public and physicians,” she said.Waldrep thinks consumers are confident and comfortable with the pharmacy's procedures and products.Shertech is the only compounding pharmacy in the state that's accredited by the Pharmacy Compounding Accreditation Board.Prescott said physicians who call ask if they're an accredited pharmacy and he anticipates that more physicians will rely on accredited pharmacies.Shertech opposes the Pharmaceutical Quality, Security and Accountability Act, because, Waldrep said, restricted access to compounded medicines would have a significant impact on patients who rely on the medications.“This bill is a reaction to the tragedy at NECC (New England Compounding Center) in an attempt to expand government oversight instead of placing focus on safety enforcement. Oversight and strict safety guidelines of compounding pharmacies were implemented prior to the fungal meningitis outbreak but there was never sufficient enforcement,” Waldrep wrote in an email.

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